The Prime Minister has signed the Government Resolution dd. November 30, 2015 # 1289 “On Restrictions to and Terms of Access of Essential Drugs Originating from Foreign Countries to State and Municipal Procurements”.
According to the document, the state procurer shall reject all the applications for supply of pharmaceuticals originating from foreign countries (except the EAEC member countries) in case of receiving two and more applications which comply with the documentation requirements and meet the following simultaneous conditions:
The country of origin is confirmed by the Certificate issued by the authorized body (entity) of the respective EAEC member country. The Certificate proforma is established by the Agreement on the Rules for Determining the Country of Goods Origin in the Commonwealth of Independent States dd. November 20, 2009.
The Resolution establishes the following exceptions to the said restrictions:
при размещении извещений о закупках лекарственных препаратов до вступления в силу постановления, а также при закупках лекарственных препаратов заказчиками, работающими на территории иностранного государства, для обеспечения своей деятельности на этой территории.
According to the documents, the supply contracts must contain the following sections:
Additionally, the information map of standard supply contract terms for pharmaceuticals and medical devices is presented in the annex to the draft orders.
Currently, price preferences of 15% are granted by the Ministry for Economic Development for domestic manufacturers when participating in state procurements. According to the Ministry for Industry and Trade, the preferences for full-cycle manufacturers (including API production) may be increased to 30%.
The Ministry of Healthcare placed for public discussions the draft Law on amendments to legislation regulating online trade of pharmaceuticals. Public discussions of the Draft “On Amendments to Legislative Acts of the Russian Federation Governing Online Trade of Pharmaceuticals” is open till December 28, 2015.
According to the draft law, online retail trade of pharmaceuticals may be carried out only by drugstores (pharmacies) holding the pharmaceutical license. The draft envisages blocking of the websites run by entities which trade pharmaceuticals without obtaining a permit.
Currently, all the websites trading pharmaceuticals online can be blocked under the pre-trial procedure.
Additionally, the Ministry suggests to impose administrative liability for violating of the rules for online trade of pharmaceuticals. The fines are supposed to constitute:
The Federal law is supposed to come into force from January 1, 2017.
The draft Resolution of the Ministry for Economic Development is aimed to support the implementation of the Federal law dd. 29.06.2015 # 188-FZ (coming in force from January 1, 2016). The draft Law envisages the liability for customers to place in the unified information system the justification of impossibility of complying with the restrictions for access of goods, works and services originated from foreign states to the state procurements.
The federal executive bodies responsible for preparing the Russian Government’s regulatory acts restricting the access of goods, works and services to the state procurements, are entitled to set out the conditions when the restrictions should not apply.
For these purposes the federal executives have to define the requirements to content of the justification why it is not possible to apply the restrictions.
The justification is to be prepared by the procurer and shall be published together with the notification on the state procurement commencement.
The amendments envisage, inter alia, the following:
Additionally, it is being considered whether a producer could be disallowed from participating in state procurements, or the state customer could be entitled to resign from contracting, if the proposed price for an Essential Drug exceeds the registered maximum ex-factory price.
The previous Pharma Bulletin issues are accessible our site.
Prepared for you by KPMG in Russia and the CIS, Healthcare & Pharmaceuticals Sector.
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